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从 DECRA 研究中学到了什么。

What can be learned from the DECRA study.

机构信息

Department of Neurosurgery, Sir Charles Gairdner Hospital, and School of Population Health, University of Western Australia, Perth, Western Australia, Australia.

出版信息

World Neurosurg. 2013 Jan;79(1):159-61. doi: 10.1016/j.wneu.2012.08.012. Epub 2012 Sep 25.

DOI:10.1016/j.wneu.2012.08.012
PMID:23022646
Abstract

BACKGROUND

There has been a resurgence of interest in the use of decompressive craniectomy for severe traumatic brain injury (TBI). Numerous studies have shown that the procedure can consistently reduce intracranial pressure (ICP), and a significant number of patients achieve a good long-term functional recovery. However, there has been debate regarding clinical indications and patient selection.

METHODS

The DECRA (Decompressive Craniectomy in Patients with Severe Traumatic Brain Injury) study compared patients who underwent early decompressive craniectomy for diffuse TBI with patients who received standard medical therapy. Of patients, 70% in the craniectomy group had an unfavourable outcome versus 51% in the standard care group (odds ratio 2.21 [95% confidence interval 1.14-4.26]; P=0.02). Based on these results, the authors concluded that decompressive craniectomy was associated with more unfavorable outcomes and that by adopting standard medical therapy rather than surgical decompression the health care system would save millions of dollars. These conclusions are not really supported by closer examination of the basic data. There were problems with randomization such that the patients in the surgical arm appeared to have sustained a more severe primary TBI, the ICP threshold of >20 mm Hg for >15 minutes did not reflect clinical practice, and there was a high crossover rate from the standard care arm to the surgical arm. Because of these problems, the DECRA trial has received a great deal of criticism, and some authorities have claimed that the results should have no influence on clinical practice. This claim is perhaps unfair, and an alternative interpretation is offered.

RESULTS

Overall, the results of the DECRA study showed that a relatively transient and mild increase in ICP (>20 mm Hg for 15 minutes as recruitment criterion) does not imply that there is significant ongoing secondary brain injury, and any potential improvement obtained by surgical decompression may well be offset by surgical morbidity.

CONCLUSIONS

The role of decompressive craniectomy when ICP continues to increase ≥20 mm Hg remains to be established. The ongoing RESCUEicp (Randomised Evaluation of Surgery with Craniectomy for Uncontrollable Elevation of Intra-Cranial Pressure) study hopes to address this issue.

摘要

背景

去骨瓣减压术治疗严重创伤性脑损伤(TBI)再次受到关注。大量研究表明,该手术可持续降低颅内压(ICP),且相当数量的患者获得了良好的长期功能恢复。然而,关于临床适应证和患者选择一直存在争议。

方法

DECRA(严重创伤性脑损伤患者去骨瓣减压术)研究比较了接受早期弥漫性 TBI 去骨瓣减压术的患者与接受标准药物治疗的患者。去骨瓣减压术组中 70%的患者预后不良,而标准治疗组中 51%的患者预后不良(比值比 2.21[95%置信区间 1.14-4.26];P=0.02)。基于这些结果,作者得出结论,去骨瓣减压术与更不利的结局相关,通过采用标准药物治疗而不是手术减压,医疗保健系统将节省数百万美元。但通过更仔细地检查基本数据,这些结论并没有得到真正支持。随机化存在问题,手术组的患者似乎遭受了更严重的原发性 TBI,ICP 阈值>20mmHg 持续>15 分钟并不反映临床实践,而且从标准治疗组到手术组的交叉率很高。由于这些问题,DECRA 试验受到了大量批评,一些权威人士声称结果不应对临床实践产生影响。这种说法或许不公平,因此提供了另一种解释。

结果

总体而言,DECRA 研究的结果表明,相对短暂和轻微的 ICP 升高(作为纳入标准的 15 分钟内 ICP>20mmHg)并不意味着存在显著的继发性脑损伤,手术减压获得的任何潜在益处很可能被手术发病率所抵消。

结论

当 ICP 持续升高≥20mmHg 时,去骨瓣减压术的作用仍有待确定。正在进行的 RESCUEicp(可控性颅内压升高的手术与颅骨切除术随机评估)研究希望解决这个问题。

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